No Additional Omapro Trials Needed, FDA Tells ChemGenex In Complete Response Letter
This article was originally published in The Pink Sheet Daily
FDA reservations mirror those outlined about need for validated assay test at March 22 ODAC meeting.
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Omacetaxine finds new life as a salvage treatment in chronic myeloid leukemia after failing to pass FDA muster for targeted therapy in patients with a particular genetic mutation. FDA allowed Teva to pool data from two open-label studies to secure approval in a third-line setting.
Omacetaxine, which was originally submitted by ChemGenex as Omapro, demonstrated response rates of 14% to 18% in patients who had failed two or more tyrosine kinase inhibitors. It enters a crowded space that is likely to add a new member, Ariad’s ponatinib, in the coming months.
FDA’s oncology office director suggests Ariad’s ponatinib and ChemGenex’s Omapro represent the best and worst of times, respectively, in the quality of development programs for personalized medicines.